Estrella Immunopharma Treats First Patient with Two EB103 Infusions in STARLIGHT-1 Dose-Expansion Phase

Earlier dose-escalation results showed no treatment-related serious adverse events among nine patients treated with EB103.

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Patient received two infusions three weeks apart at the recommended Phase II dose; no treatment-related serious adverse events observed through the first month of follow-up

EMERYVILLE, Calif.--(BUSINESS WIRE)-- Estrella Immunopharma, Inc. (NASDAQ: ESLA) (“Estrella” or the “Company”), a clinical-stage biopharmaceutical company developing CD19- and CD22-targeted ARTEMIS^® T-cell therapies to treat cancers and autoimmune diseases, today announced that the first patient who received two infusions, each at 5 × 10⁶ EB103 T cells/kg, three weeks apart, in the dose-expansion phase has tolerated the study drug well in the first month, with no treatment-related serious adverse events (SAEs) reported. STARLIGHT-1 is evaluating EB103, Estrella’s investigational CD19-redirected ARTEMIS^® T-cell therapy, in patients with relapsed/refractory (R/R) B-cell non-Hodgkin's lymphoma (NHL).

In the dose-escalation portion of the STARLIGHT-1 trial, EB103 demonstrated a 100% complete response (CR) rate at Month 1 in all evaluable patients in the high-dose cohort. Notably, no treatment-related SAEs have been reported among the nine patients treated with EB103 in the dose-escalation phase, the majority of whom presented with high-risk disease. All evaluable Phase I patients without central nervous system (CNS) involvement who achieved a CR remained in CR at the 9-month assessment.

"Administering two full doses of EB103 within three weeks, with no treatment-related serious adverse events observed to date, is an encouraging start to our expansion phase," said Cheng Liu, PhD, Chief Executive Officer of Estrella. "While this is an early result from a single patient, it supports our rationale for evaluating multiple dosing with the goal of potentially delivering deeper responses in the most difficult-to-treat NHL patients, an approach we believe the safety profile observed with EB103 to date allows us to explore. We look forward to enrolling additional patients and to reporting additional efficacy and safety data from the expansion cohort."

The ongoing expansion phase of the Phase I/II clinical trial for EB103 is designed as a multi-center, open-label study intended to further evaluate the safety and efficacy of EB103 at the RP2D in subjects (≥ 18 years of age) who have R/R B-cell NHL. Estrella expects that data from this expansion cohort will be used to inform the pivotal trial strategy for EB103. As of the date of this press release, active clinical sites for the trial are UC Davis Comprehensive Cancer Center, Baylor Scott & White Research Institute, Oregon Health & Science University, University Hospitals Cleveland Medical Center, and Intermountain Health LDS Hospital. Further details of the trial can be found at www.clinicaltrials.gov under NCT identifier NCT06343311.

About EB103

EB103, a T-cell therapy, also referred to as Estrella’s “CD19-Redirected ARTEMIS^® T-Cell Therapy,” utilizes ARTEMIS^® technology licensed from Eureka Therapeutics, Inc. (Eureka), Estrella’s parent company. Unlike a traditional CAR-T cell, the unique design of an ARTEMIS^® T-Cell, such as EB103, allows it to be activated and regulated upon engagement with cancer targets through a cellular mechanism that more closely resembles that of an endogenous T-cell receptor. Once infused, EB103 T cells bind to and destroy CD19-positive cancer cells.

About Estrella Immunopharma

Estrella is a clinical-stage biopharmaceutical company developing CD19- and CD22-targeted ARTEMIS^® T-cell therapies to treat cancers and autoimmune diseases. Estrella’s mission is to harness the evolutionary power of the human immune system to transform the lives of patients fighting cancer and other diseases. To accomplish this mission, Estrella’s lead product candidate, EB103, utilizes Eureka’s ARTEMIS^® technology to target CD19, a protein expressed on the surface of almost all B-cell leukemias and lymphomas. Estrella is also developing EB104, which utilizes Eureka’s ARTEMIS^® technology to target not only CD19, but also CD22, another protein expressed on the surface of most B-cell malignancies.

For more information about Estrella, please visit www.estrellabio.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, those regarding the potential safety, efficacy and therapeutic benefits of EB103 and Estrella’s other ARTEMIS^® T-cell product candidates; the potential benefits of a multiple-dose regimen of EB103, including the potential for deeper or more durable responses; the tolerability of EB103 and the durability of responses observed to date, which are based on a small number of patients and limited follow-up; the design, conduct, progress and timing of the STARLIGHT-1 Phase I/II clinical trial and any future clinical trials of EB103; Estrella’s expectations regarding the recommended Phase II dose, the expansion phase and the use of data from the expansion phase to inform any future pivotal trial strategy; Estrella’s ability to advance EB103 and EB104 in development; and the expected timing of enrollment and dosing of additional patients and of the reporting of data from the expansion cohort. These statements may be identified by the use of forward-looking expressions, including, but not limited to, “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors that could cause actual results, levels of activity, performance, or achievements to differ materially from those expressed or implied by these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed under “Risk Factors” and elsewhere in our filings with the Securities and Exchange Commission. The forward-looking statements in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. Information contained on, or accessible through, Estrella’s website or the websites referenced in this press release is not incorporated by reference into, and does not form a part of, this press release.

View source version on businesswire.com: https://www.businesswire.com/news/home/20261015515780/en/

Investor Relations
Estrella Immunopharma, Inc.
IR@estrellabio.com

Source: Estrella Immunopharma, Inc.

Key Terms

serious adverse events medical

Serious adverse events are significant problems or negative outcomes that occur during a medical treatment or clinical trial, such as severe side effects, hospitalizations, or life-threatening conditions. They matter to investors because such events can impact a company's reputation, lead to regulatory scrutiny, or delay the development of new products, ultimately affecting the company’s financial performance.

complete response medical

A complete response is a positive outcome in which a company’s efforts to address issues or questions fully resolve the problem, often meaning that no further action or investigation is needed. For investors, it signals that concerns have been thoroughly addressed, which can boost confidence in the company's stability or decision-making. Think of it like a doctor fully treating an illness, leaving no remaining symptoms.

relapsed/refractory medical

Relapsed/refractory describes a disease, usually cancer, that has returned after treatment (relapsed) or that did not respond to initial therapy (refractory). For investors this signals a high medical need and a defined patient group for new treatments — like a market of cars that won’t start with a standard key — which can affect drug development priorities, trial designs, potential pricing and commercial opportunity.

rp2d medical

The Recommended Phase 2 Dose (RP2D) is the drug dose and schedule chosen after early human testing as the best balance between safety and potential effectiveness for larger clinical trials. Investors watch RP2D because it determines whether a drug advances to more extensive testing, shapes the size, cost and timeline of development, and affects the odds of eventual approval and commercial returns—like finalizing a recipe before scaling up production.